Data Foundry

Medical device recalls 2025

9 Coated Super Tampons and 9 Nude Super Tampons — Class II medical device recall Z-0379-2026

Ongoing recall by DAYE (ANNE'S DAY LTD), reported 2025-11-05, distributed nationwide. Product lacks 510(k) clearance.

Recall numberZ-0379-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmDAYE (ANNE'S DAY LTD), London, N/A, United Kingdom
Recall initiated2025-02-17
Classified2025-10-28
Reported by FDA2025-11-05
DistributedNationwide (US)
Quantity3,074 packages
UPC / GTIN / UDI-DI05060994740608
Lot numbers20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001615, CR001616, CR001616CS002164, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001902, CR001619, CR001623, CR001625, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001655CS002196, CR001661, CR001661NR002015, CR001662, CR003000, CR003000NR002173, CR003001, CR003002, CR003005, CR003008 and 46 more
Model numbersFG-TMP-RET00090009

Product

9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;

Reason for recall

Product lacks 510(k) clearance.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0379-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.